BEUDAMED
    3,776 results · 11ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Authorized Representative: Lotus Nl B.V. ×

    AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)

    Device
    EU IVDR · Eu Ivd Class B ·Zybio Inc.·On the market·32 countries

    Aoralscan 3

    Device
    EU MDR · Eu Md Class 1 ·Shining 3D Tech Co., Ltd.·On the market·2 countries

    INFUSION CONTROLLERS - OTHER

    Device
    EU MDR · Eu Md Class 1 ·Shandong Caremed Medical Products Co., Ltd.·On the market·3 countries

    cTnI/CK-MB/Myoglobin Test Kit（colloidal gold immunochromatographic assay）

    Device
    EU IVDD · Eu Ivd General ·Kangmei Tianhong Biotech (Beijing) Co., Ltd.·On the market

    CANCER ANTIGEN 50

    Device
    EU IVDD · Eu Ivd General ·Sansure Biotech Inc.·On the market

    ADRENOCORTIOTROPIC HORMONE

    Device
    EU IVDD · Eu Ivd General ·Sansure Biotech Inc.·On the market

    Xiamen Wiz Biotech Co., Ltd.

    Manufacturer
    🇨🇳 China·4 Basic UDI-DIs·4 Devices·1 Importer

    SHANGHAI ZJ BIO-TECH CO., LTD

    Manufacturer
    🇨🇳 China·297 Basic UDI-DIs·326 Devices·2 Importers·TÜV Rheinland LGA Products GmbH

    Sansure Biotech Inc.

    Manufacturer
    🇨🇳 China·1252 Basic UDI-DIs·1376 Devices·4 Importers·TÜV SÜD Product Service GmbH, CeCert Sp. z o.o., CeCert Sp. z o.o., CeCert Sp. z o.o., CeCert Sp. z o.o., CeCert Sp. z o.o., CeCert Sp. z o.o., and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

    Adrenocorticotropic Hormone Chemiluminescence Immunoassay Kit

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Sansure Biotech Inc.·1 device

    Carbohydrate Antigen50 Assay Kit (Chemiluminescent Immunoassay)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Sansure Biotech Inc.·1 device

    Zybio Inc.

    Manufacturer
    🇨🇳 China·147 Basic UDI-DIs·212 Devices·3 Importers

    Changsha Sinocare Inc.

    Manufacturer
    🇨🇳 China·67 Basic UDI-DIs·68 Devices·1 Importer·TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH

    Changsha Sinocare Inc.

    Manufacturer
    🇨🇳 China·1 Importer·TÜV Rheinland LGA Products GmbH

    RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER

    Device
    EU IVDD · Eu Ivd General ·Xiamen Wiz Biotech Co., Ltd.·On the market

    VIROLOGY - RT & POC - OTHER

    Device
    EU IVDD · Eu Ivd General ·Xiamen Wiz Biotech Co., Ltd.·On the market

    VIROLOGY - RT & POC - OTHER

    Device
    EU IVDD · Eu Ivd General ·Xiamen Wiz Biotech Co., Ltd.·On the market

    INFLUENZA A AND /OR B - RT & POC

    Device
    EU IVDD · Eu Ivd General ·Xiamen Wiz Biotech Co., Ltd.·On the market

    25-HYDROXYVITAMIN D

    Device
    EU IVDD · Eu Ivd General ·Sansure Biotech Inc.·On the market

    25-HYDROXYVITAMIN D

    Device
    EU IVDD · Eu Ivd General ·Sansure Biotech Inc.·On the market